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The CardioFocus Deflectable Sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The HeartLight® Deflectable Sheath is a sterile, disposable device which provides a conduit for catheter introduction into the vasculature and into the chambers of the heart. The Deflectable Sheath is able to move its distal section in one direction in a single plane and is activated by a rotating knob at the front of the device handle. The deflection of the sheath and the torquing of the device allow the distal end of the sheath to be positioned at the ostium of pulmonary veins.

The provided document describes the HeartLight Deflectable Sheath, a medical device, and its comparison to a predicate device for the purpose of a 510(k) premarket notification. The information pertains to engineering testing and biocompatibility rather than the performance of an AI/ML powered device impacting diagnostic accuracy. Therefore, many of the requested elements for an AI/ML study, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable in this context.

However, I can extract the acceptance criteria and performance data as presented for this device.

1. Table of Acceptance Criteria and Reported Device Performance

The document details performance and functional requirements testing for the HeartLight Deflectable Sheath, primarily through a comparison to the predicate device, FlexCath® Advance™ Steerable Sheath (K123591), and a reference device, HeartSpan® Steerable Introducer (K132164). The acceptance criteria are generally implied by stating "Same" or "Similar" to the predicate, with specific values provided where there are differences.

Study Proving Device Meets Acceptance Criteria:

The study involved a series of Design Verification tests and Biocompatibility tests.

The document states: "Design Verification testing were performed for the HeartLight 12F Deflectable Sheath to verify that design outputs meet relevant performance and functional requirements and conforms to the intended use of the device." And "The device specification requirements for functionality, performance specifications, physical characteristics, safety characteristics, labeling, packaging and shipping, shelf life, and sterilization all passed the specific tests and engineering evaluations. The testing demonstrates that the device does not raise questions of safety or effectiveness when compared to the predicate."

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document does not specify the exact sample size for each performance test (e.g., how many sheaths were tested for deflection, kink resistance, etc.). The testing appears to be bench testing of the device itself rather than human-subject data.
• Data Provenance: The data is generated from bench testing and laboratory biocompatibility studies of the device components. There is no information regarding country of origin of the data as it's not human subject data. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Not Applicable. This is a medical device clearance based on engineering performance and biocompatibility bench testing, not an AI/ML diagnostic or prognostic device requiring expert-established ground truth from patient data.

4. Adjudication method for the test set:

• Not Applicable. As above, no human expert adjudication on clinical cases was involved. The evaluation relied on predefined engineering specifications and ISO standards for biocompatibility.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI/ML powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is not an AI/ML powered device. The "standalone" performance here refers to the device's physical and functional attributes in bench tests.

7. The type of ground truth used:

• Engineering Specifications and ISO Standards: For performance testing (e.g., deflection angle, usable length, hemostasis, kink resistance), the "ground truth" was the predefined engineering specifications and criteria that the device needed to meet, often referenced against the predicate device's characteristics.
• ISO 10993-1 Standards: For biocompatibility, the "ground truth" was compliance with the requirements outlined in ISO 10993-1 for an external communicating device in contact with circulating blood for less than 24 hours. Specific tests included: C3a Complement Activation Assay, SC5b-9 Complement Activation Assay, ASTM Partial Thromboplastin Time, USP Pyrogen Study, ISO Systemic Toxicity Study in Mice, ISO Intracutaneous Study in Rabbits, ASTM Hemolysis Study, Cytotoxicity Study Using the ISO Elution Method, ISO Guinea Pig Maximization Sensitization Test, and Thromboresistance Study in the Sheep (Heparinized Model).

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML powered device. The device itself is manufactured; it does not have a "training set" in the AI/ML sense.

9. How the ground truth for the training set was established:

• Not Applicable. See point 8.

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